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NCT02215512 · ClinicalTrials.gov registry record · Phase 1
Dose-Escalation Study of RRx-001 in Combination With Whole Brain Radiation in Subjects With Brain Metastases
A Phase 1 study of Brain Metastases, sponsored by EpicentRx.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 5
- Study locations
NCT02215512: Completed Phase 1 study of Brain Metastases, sponsored by EpicentRx.
NCT02215512 is a Phase 1 study of Brain Metastases that has completed, run by EpicentRx. The registered enrollment target is 29 participants, below the 213-participant average among 67 other Brain Metastases trials with a reported enrollment target (86% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02215512, a Phase 1 study of Brain Metastases, has completed, sponsored by EpicentRx.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 5
- Study locations
Study Summary
In this dose-escalation study, the safety and tolerability of escalating dose levels of RRx-001 administered intravenously twice a week in subjects with brain metastases receiving whole brain radiation therapy (WBRT) will be assessed. Once a maximum tolerated dose is identified, further (up to approximately 30) participants will be recruited. The study will use MRI to monitor changes in tumor blood flow associated with RRx-001.
Primary Outcome
To identify the maximum tolerated dose (MTD) of RRx-001 in combination with WBRT, defined as the dose of RRx-001 associated with a 20% probability of dose-limiting toxicity (DLT) in subjects with brain metastases
Conditions Studied
Interventions
- DRUG RRx-001 + WBRT
Study Locations (5)
Michigan
- University of Michigan - Ann Arbor
- Allegiance Health - Jackson
California
- Providence Saint John's Health Center - Santa Monica
Missouri
- Washington University School of Medicine - St Louis
New Jersey
- The Cancer Institute of New Jersey (Rutgers University) - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2015-02-06 |
| Est. Completion | 2020-11-12 |
| Phase | Phase 1 |
What the finished NCT02215512 record still lists
NCT02215512 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 213-participant average among 67 other Brain Metastases trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Brain Metastases appearing as the primary indexed condition, and to 1 intervention - of which RRx-001 + WBRT is the first listed.
NCT02215512 lists 5 locations in 4 states (Michigan, California, Missouri).
Frequently Asked Questions
What is clinical trial NCT02215512 about?
NCT02215512 is a clinical study titled "Dose-Escalation Study of RRx-001 in Combination With Whole Brain Radiation in Subjects With Brain Metastases". In this dose-escalation study, the safety and tolerability of escalating dose levels of RRx-001 administered intravenously twice a week in subjects with brain metastases receiving whole brain radiation therapy (WBRT) will be assessed. Once a maximum tolerated dose is identified, further (up to appro...
What is the current status of trial NCT02215512?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2015-02-06. Estimated completion is 2020-11-12.
What conditions does trial NCT02215512 study?
This clinical trial studies the following conditions: Brain Metastases.
What interventions are being tested in trial NCT02215512?
The interventions under investigation include: RRx-001 + WBRT (DRUG).
Who is sponsoring clinical trial NCT02215512?
This trial is sponsored by EpicentRx, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02215512 being conducted?
This trial has 5 study locations across California, Michigan, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Brain Metastases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02215512's enrollment target sits among peer trials
29 45th of 67 higher than 23 of 67 other Brain Metastases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Metastases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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